Table 2.
Change in body composition by randomized group
| Endpoint | Randomized Group |
Baseline Mean (SD) |
52 Week Mean Change (SE) |
Estimated Treatment Difference (95% CI) |
|---|---|---|---|---|
| Body weight, kg | Control | 89.3 (16.9) | −0.27 (0.63) | 0.00—Reference |
| Exercise | 89.7 (16.2) | −0.33 (0.66) | −0.06 (−1.85, 1.72) | |
| Diet | 89.9 (16.5) | −5.66 (0.69)a | −5.39 (−7.24, −3.55)b | |
| Exercise & Diet | 91.2 (16.3) | −6.95 (0.67)a | −6.68 (−8.46, −4.90)b | |
| Fat mass, kg | Control | 40.9 (10.7) | −0.94 (0.51) | 0.00—Reference |
| Exercise | 40.3 (10.9) | −0.79 (0.52) | 0.14 (−1.30, 1.59) | |
| Diet | 40.6 (10.3) | −4.52 (0.52)a | −3.59 (−5.00, −2.17)b | |
| Exercise & Diet | 41.7 (10.2) | −5.22 (0.53)a | −4.28 (−5.71, −2.84)b | |
| Visceral adipose tissue, cm2 | Control | 158.6 (57.2) | −6.59 (3.63) | 0.00—Reference |
| Exercise | 164.8 (75.5) | −12.09 (3.90)a | −5.50 (−15.73, 4.73) | |
| Diet | 158.2 (62.2) | −27.87 (3.68)a | −21.28 (−31.37, −11.19)b | |
| Exercise & Diet | 155.0 (69.6) | −26.46 (3.67)a | −19.87 (−30.03, −9.70)b | |
| Subcutaneous adipose tissue, cm2 | Control | 515.2 (128.0) | −5.05 (7.17) | 0.00—Reference |
| Exercise | 491.9 (133.2) | 2.64 (7.16) | 7.69 (−12.20, 27.58) | |
| Diet | 507.2 (125.9) | −44.59 (7.40)a | −39.53 (−59.85, −19.23)b | |
| Exercise & Diet | 502.7 (136.1) | −50.24 (7.46)a | −45.19 (−65.14, −25.23)b | |
| Lean mass, kg | Control | 49.1 (7.6) | −0.06 (0.25) | 0.00—Reference |
| Exercise | 50.1 (6.6) | 0.36 (0.25) | 0.42 (−0.25, 1.10) | |
| Diet | 49.9 (7.3) | −0.88 (0.24)a | −0.82 (−1.50, −0.15)b | |
| Exercise & Diet | 50.4 (7.3) | −1.30 (0.24)a | −1.24 (−1.92, −0.56)b | |
| Appendicular lean mass, kg | Control | 21.4 (3.8) | −0.05 (0.11) | 0.00—Reference |
| Exercise | 22.2 (3.7) | 0.18 (0.11) | 0.23 (−0.08, 0.54) | |
| Diet | 22.0 (3.8) | −0.37 (0.11)a | −0.32 (−0.63, −0.01)b | |
| Exercise & Diet | 22.3 (3.8) | −0.51 (0.11)a | −0.46 (−0.77, −0.15)b | |
| Bone mineral density, g/cm2 | Control | 1.12 (0.12) | −0.007 (0.004) | 0.000—Reference |
| Exercise | 1.12 (0.13) | −0.007 (0.004) | −0.001 (−0.012, 0.010) | |
| Diet | 1.16 (0.13) | −0.002 (0.004) | 0.005 (−0.006, 0.016) | |
| Exercise & Diet | 1.15 (0.14) | −0.003 (0.004) | 0.003 (−0.008, 0.014) |
Note: Unobserved data were multiply imputed using predictive mean matching and analyzed using a repeated measures analysis of covariance model. Models are adjusted for the baseline value of the dependent variable, and randomization stratification factors including age, receipt of radiotherapy, number of lymph nodes resected, lymphedema severity, and body mass index.
a
P<0.05 (two-sided) compared with baseline (within group).
b
P<0.05 (two-sided) compared with control, adjusted for multiplicity.